COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses

Not Applicable

Completed

• Conditions: Saliva; Mouthwash; COVID19
• Interventions: Device: mouthrinse without bêta-cyclodextrin and citrox; Device: mouthrinse with bêta-cyclodextrin and citrox

• Registration Number: NCT04352959
• Lead Sponsor: Claude Bernard University

Brief Summary

Given the current lack of effective COVID-19 treatment, it is necessary to explore alternative methods to contain the spread of the infection, focusing in particular on its mode of transmission. The modes of person-to-person transmission of SARS-CoV-2 are direct transmission, such as sneezing, coughing, transmission through inhalation of small droplets, and transmission through contact, such as contact with nasal, oral and eye mucous membranes. SARS-CoV-2 can also be transmitted directly or indirectly through saliva. The use of antiviral mouthrinses may be used as adjunctive therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-20
• Study Start: 2020-04-27
• Primary Completion: 2020-12-11
• Study Completion: 2020-12-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• Clinical diagnosis of Covid-19 infection by the patient's general practitioner and hospital doctor
• Clinical signs started less than 8 days ago.
• Virological confirmation
• Understanding and acceptance of the trial.
• Written agreement to participate in the trial

Exclusion Criteria

• Pregnancy
• Breastfeeding
• Inability to comply with protocol
• Lack of written agreement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mouth rinse without antiviral	mouthrinse without bêta-cyclodextrin and citrox	-
mouth rinse with antiviral	mouthrinse with bêta-cyclodextrin and citrox	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline amount of SARS-CoV-2 in salivary samples at 7 days	7 days	Quantitative PCR experiments will be performed and a quantitative analysis of the salivary samples will be made

Secondary Outcome Measures

Name	Time	Method
Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 7 days	7 days	Quantitative PCR experiments will be performed and a quantitative analysis of the nasal samples will be made

Trial Locations

Locations (4)

Hospital Center Emile Roux; 🇫🇷 Le Puy en Velay, France

Hospital Center Saint Luc Saint Joseph; 🇫🇷 Lyon, France

Clinic of the Protestant Infirmary in Lyon; 🇫🇷 Caluire-et-Cuire, France

Intercommunal Hospital Center of Mont de Marsan; 🇫🇷 Mont de Marsan, France